Search Results

The PERLA® TL Posterior Thoraco-lumbar Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior noncervical pedicle screw fixation in pediatric patients, the PERLA® TL Posterior Thoraco-lumbar Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL Posterior Thoraco-lumbar Fixation System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PERLA® TL Posterior Thoraco-lumbar Fixation System consists of a range of screws, rods, set screws, hooks, rod connectors and cross-connectors. These connecting components can be rigidly locked to the rod in a variety of configurations to be adapted for the individual case. The PERLA® TL Posterior Thoraco-lumbar Fixation System is manufactured from medical grade titanium alloy and medical grade cobalt chromium conforming respectively to standards ASTM F136 and ASTM F1537. The PERLA® TL Posterior Thoraco-lumbar Fixation System implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

The provided text describes a 510(k) premarket notification for the PERLA® TL Posterior Thoraco-lumbar Fixation System. This submission is an "Extension of the range" and an "MRI update" for an already cleared device.

Crucially, the document explicitly states that this is an extension of an existing device and focuses on mechanical testing of new components (rods, rod connectors) and MRI safety evaluations. It does NOT describe a study evaluating the clinical performance or diagnostic accuracy of an AI or software device. Therefore, many of the requested points related to AI performance, such as sample sizes for test and training sets, expert ground truth, adjudication methods, and MRMC studies, are not applicable to this submission.

However, I can extract the relevant information regarding the acceptance criteria and the studies performed for this specific device extension.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The acceptance criteria for this device extension are primarily focused on the safety and performance of the added mechanical components and their compatibility with MRI environments, as well as adherence to material and manufacturing standards.

Regarding the points not applicable to this specific submission (as it's a hardware extension and MRI update, not an AI/software performance study):

• 2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This document describes mechanical and MRI safety testing, not clinical data analysis. For mechanical testing, samples are typically physical devices.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. No expert ground truth was established as this is not a diagnostic AI device.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication method was used as this is not a diagnostic AI device.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.
• 6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This is a medical implant, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Ground truth for diagnostic accuracy is not relevant here. The "ground truth" for mechanical testing is adherence to established engineering standards (ASTM).
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
• 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device requiring a training set.

Ask a specific question about this device